MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U357584
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was not returned for evaluation.Therefore, the investigation of the reported material rupture is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model u357584 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from one source.This event did not involve a patient as there was no patient contact.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the malfunction indicated that model u357584 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from one source.This event did not involve a patient as there was no patient contact.
Additional Manufacturer Narrative
H10: for the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.Tear and leak were confirmed for the returned device.The tear is the cause of the leak; however, the definitive root cause for the tear could not be determined.The device is labeled for single use.H10: g4 h11: h2, h6 (device codes, method, results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9597966
• Report Number: 2020394-2020-00542
• Device Sequence Number: 491997
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMDU0047
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1